Kornimate/medical-research-clean huggingface dataset:
phase iii study of a topical gel formulation for treatment and prevention of raynaud's phenomenon

Conditions: Raynaud's Disease; Scleroderma; Autoimmune Diseases

Summary: the purpose of this research study is to test the safety, tolerability, and effectiveness of topical amphimatrix with nitroglycerin (mqx-503) to relieve raynaud's symptoms and increase blood flow to the fingers.

the purpose of this clinical study is to determine, in a controlled fashion, the ability of topical amphimatrix formulation with nitroglycerin (mqx-503) to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of raynaud's events, decrease the duration of raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of raynaud's patients. the study will include patients with moderate to severe primary raynaud's phenomenon and with raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.

Eligibility criteria:
inclusion criteria: * outpatients, 18 years to 70 years. * patients with a clinical diagnosis of raynaud's phenomenon. * patients who are willing to discontinue current vasodilator therapies. * patients who agree not to use any other investigational medications or approved therapies to treat raynaud's phenomenon and its symptoms while participating in this study. * negative pregnancy test in fertile women. * patients who are able to give written informed consent and comply with all study requirements. exclusion criteria: * patients who concurrently use any nitrate medication or medications known to interact with nitroglycerin. * patients who concurrently use any medication or device which might interfere with the study medication. * patients who have a known allergy to nitroglycerin or common topical gel ingredients. * patients with a history of headaches. * patients who have a history of an unstable medical problem. * patients with cognitive or language difficulties. * patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension. * patients who participated in a study of any investigational drug within four weeks prior to visit 1. * patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal. * patients who have had major surgery within six months of visit 1. * patients with interfering skin conditions. * pregnant or nursing women.

Keywords: raynaud's
effect of selective strengthening of peroneus longus on pain , joint alignment and foot function in hallux valgus

Conditions: Hallux Valgus

Summary: purpose of this study is to measure change in hallux valgus angle (hva )as measured by kinovea software change in pain as measured by numerical pain rating scale (nprs) change in function as measured by foot function index (ffi )egyptian version with the peroneus longus strengthening exercise versus the use of conventional physical therapy programme in cases of hallux valgus patients


Eligibility criteria:
inclusion criteria: * all patients must be diagnosed as having mild to moderate hallux valgus (with hallux valgus angle between 15-40 degrees) * patients aging between 18-60 . * patients must report pain and limited function . * patients must report that they are not undergoing physiotherapy , not using orthosis , dynamic splinting exercises for hallux valgus exclusion criteria: * patients diagnosed with systematic diseases such as rheumatoid arthritis . * cognitive or mental illness. * hallux rigidus or limitus . * history of surgery to foot of hallux . * previous use of foot orthosis .

Keywords: peroneus longus hallux valgus angle hva kinovea software foot function index hallux pain
non-culprit vessels for st-segment elevation myocardial infarction

Conditions: Conservative Pharmacotherapy; Staged Percutaneous Coronary Intervention; Non-culprit Vessels; ST-Segment Elevation Myocardial Infarction

Summary: to compare the different effect of conservative pharmacotherapy and staged percutaneous coronary intervention (spci) on significant non-culprit lesions in patients with st-segment elevation myocardial infarction (stemi) at presentation remains controversial


Eligibility criteria:
inclusion criteria: * age 18 to 75 with continuous ischemic chest pain for ≥ 30 minutes and st-segment of electrocardiographic leads between v2 and v3 elevated ≥ 0.2 mv (or ≥ 0.1 mv in ≥ 2 other continuous electrocardiographic leads), cardiac troponin i (ctn i) elevation of \> 0.05 ng/ml, coronary arteriography within 12 hours after the onset of symptoms indicating lesion in culprit vessel with thrombolysis in myocardial infarction (timi) flow grade 0 to 1, merely underwent ppci. additionally, coronary arteriography corroborates lesions in non-culprit vessel (besides the culprit vessel, there are ≥ 70% stenoses in one or more coronary vessels in which diameters were ≥ 2 mm). exclusion criteria: * left main coronary artery disease, cardiogenic shock, complete left bundle branch block (clbbb) ppci treated culprit and non-culprit vessels, ppci failure patients with postsurgical haemodynamic instability or spontaneous ischemia, ≥ 70% stenoses of vessels remained during the hospitalization after staged pci, history of pci or coronary artery bypass grafting (cabg), history of chronic cardiac failure, bleeding diathesis, prior administration of thrombolytic therapy, known thrombopenia or leucopenia, sever liver and kidney dysfunction, active infection, immune system and connective tissue diseases, known contraindications to aspirin or heparin, life expectancy \< 1 year, had major procedure within 3 months, uncontrolled hypertension, ischemic stroke within 30 days, hemorrhagic stroke, intracranial diseases including and arteriovenous malformation, extensive traumatic cerebral infarction within 6 weeks, oral anticoagulant therapy, severe myocardial infarction related complications and perioperative death
preoperative inspiratory muscle training in gastroplasty

Conditions: Obesity

Summary: the purpose of this study is to assess the effect of preoperative inspiratory muscle training in patients with grade iii obesity undergoing bariatric surgery. it will be a double-blind randomized controlled clinical trial with volunteers allocated in two groups that will be compared according to postoperative evolution (pulmonary complications, lung function, strength and endurance of the respiratory muscles and respiratory system resistance).

the prevalence of obesity has a significantly increase in recent years and represents a public health problem due to the increased risk of mortality from various causes. changes in respiratory system arising from obesity are well established and they include a reduction in compliance with an increased ventilatory work and oxygen consumption with breathing. bariatric surgery is an alternative surgical treatment of obesity and patients who undergo this surgery are susceptible to post operative pulmonary complications as a result of obesity and also abdominal surgery. the inspiratory muscle training (imt) used in pre or post operative period can improve muscle strength and endurance, beyond the perception of dyspnea.there are suggestions that the preoperative training may contribute to a best post operative evolution in patients, but these benefits are not clearly defined in the literature. the objective is to evaluate the effects of preoperative imt in post operative patients undergoing gastroplasty. there will be 40 patients of bariatric surgery group in ribeirão preto medical school of both sexes, bmi\>40 kg/m2 and with the appropriate inclusion criteria.they will be assessed by pulmonary function tests, measurement of strength and endurance of respiratory muscles, submaximal exercise tests, dyspnea and quality of life scales. all patients will receive standard treatment and will be randomly divided into two groups, named control group and training group, who will be trained for 4 weeks preoperatively. the patients will be reassessed after 4 weeks of training and on the 15th postoperative return day. the evolution data about pulmonary complications will be collected from the medical records, notes of the medical staff and physical therapy routine service.

Eligibility criteria:
inclusion criteria: * patients attending the bariatric surgery's ambulatory; * patients presenting body mass index (bmi) ≥ 40 kg/m2. exclusion criteria: * acute or chronic pulmonary diseases; * smoking; * not stable cardiovascular diseases; * decompensated diabetes.

Keywords: obesity respiratory muscle training bariatric surgery breathing exercises gastroplasty
initial stay times and heat mitigation controls for uncompensable occupational heat stress - part ii

Conditions: Core Temperature; Heat Stress, Exertional; Heat Fatigue; Exercise

Summary: workplaces rely on upper heat stress limits provided by the american conference of governmental industrial hygienists (acgih) to manage the health and safety of workers in hot environments. this is primarily achieved by interspersing work with rest periods, the length of which is dictated by environmental conditions and work intensity, to maintain core temperature at or below 38.0°c (equivalent to a 1°c increase in body core temperature above resting levels). however, these guidelines employ a "one size fits all" approach to exposure limits that does not consider individual variation (e.g., age) between workers. moreover, they fail to provide direction on the safe, initial stay times before these heat-mitigation controls should be employed (i.e., rest breaks) in conditions exceeding upper heat stress limits. while recent work has generated estimates of the initial stay times for young to older men before heat-mitigation controls are required for moderate-intensity work, information on initial stay times for heavy-intensity work remains to be assessed. this project will assess the initial stay times for heavy-intensity work for a single work bout as well as for a second work bout that is preceded by an extended rest period such as a lunch break and a work bout performed on the next day to determine if refinements in initial stay times across these periods may be required. further, the investigators will evaluate if the application of recommended work-rest allocations thereafter would alleviate increases in core temperature for the duration of the work period (e.g., start of shift versus post-lunch period). given the known age-differences in heat loss that can modulate core temperature regulation during an exercise-heat stress, the investigators will assess responses response in young and older adults.


Eligibility criteria:
inclusion criteria: * young (18-30 years) and older adults (50-69 years) * habitually active, not endurance trained (\<2 sessions per week, \<150 minutes per week) * non-smoking * english or french speaking * ability to provide informed consent exclusion criteria: * pre-existing health conditions (e.g., diabetes, hypertension) * use of medication deemed to significantly modulate thermoregulatory function and heat tolerance (e.g., antidepressants, antihistamines, diuretics) * engaged in jobs and/or activities that involve frequent exposure to hot environments (e.g., regular sauna use)

Keywords: heat exposure heat strain body temperature thermoregulation occupational heat stress uncompensable heat stress aging
enhanced virologic monitoring for pregnant and postpartum women with hiv

Conditions: HIV Infections; Viremia; Pregnancy Related

Summary: the goal of this study is to learn about supporting pregnant and postpartum women living with hiv with treatment adherence. the investigators will conduct a pilot study of an intervention that includes peer counseling about viral load levels and rapid delivery of viral load results. the investigators will evaluate the feasibility of the intervention, and will assess whether it improves viral suppression 6 months following the intervention, compared to historical controls.

the investigators will examine the use of more frequent virologic monitoring with enhanced communication around low-level viremia as a strategy to identify and support pregnant and postpartum women at risk of virologic failure. virologic monitoring itself can reinforce adherence in stable patients, and more frequent monitoring can detect potential adherence challenges early. notably, low-level viremia is a strong predictor of subsequent virologic failure, and the lowest level associated with perinatal transmission is not known. the pilot study will run for 6 months at 4 ministry of health facilities in kisumu county, kenya; 275 participants will be enrolled. prior to the pilot study, 125 controls will be enrolled prospectively, and 150 controls will be abstracted from records from the prior year.

Eligibility criteria:
inclusion criteria: * women living with hiv * on antiretroviral treatment * either pregnant in the 3rd trimester, or, postpartum within 6 months of delivery exclusion criteria: * n/a
a prospective, post-market, multi-center feasibility study of the bioduct® meniscal repair device

Conditions: Knee Meniscus Tear

Summary: to demonstrate repair of the meniscus at 6 months, as evaluated by mri, will be observed; and clinical qualitative assessments will improve from preoperative to postoperative time points with the bioduct® meniscal repair device.

to demonstrate repair of the meniscus 6 months postimplantation of the bioduct® meniscal repair device, utilizing mri. to evaluate clinical success by comparing the following qualitative criteria at 2 years postoperative to preoperative findings: effusion, swelling, pain, catching, locking, focal joint line pain and mechanical symptoms, if present preoperative. clinical success is defined as no worsening for any of these criteria and improvement in at least one of these criteria.

Eligibility criteria:
inclusion criteria: * a. patient has signed an irb approved, study specific informed patient consent form. * b. patient is a male or non-pregnant female age 45 years or younger at time of study device implantation. * c. patient is a candidate for repair of one longitudinal vertical tear (bucket handle) fully located in the red-white (vascular-avascular) zone of the meniscus (3-5 mm from the synovial-meniscus junction) or repair of one longitudinal vertical tear (bucket handle) primarily located in the red-white zone of the meniscus, but partially (\ 5 mm from the synovial-meniscus junction). * d. patient does not require more than three bioduct® meniscal repair devices for the meniscal tear. * e. patient requires suture only for fixation at the site where the study device will be used. * f. patient is willing and able to comply with postoperative scheduled mri and clinical evaluations and rehabilitation. exclusion criteria: * g. patient has a body mass index (bmi) \> 35. * h. patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. * i. patient has horizontal, transverse, degenerative complex tears. * j. patient has acl and/or pcl deficiencies within the operative knee and is not undergoing concomitant repair of these deficiencies. * k. patient requires bilateral meniscal repair. * l. patient requires meniscectomy. * m. patient presents with abnormal degenerative osteoarthritis of the joint \[e.g. international cartilage repair society (icrs) grade iii or higher and/or modified outerbridge grade iii or higher\]. * n. patient has undergone previous meniscal repair to the operative knee. * o. patient has a knee joint with greater than 5º anatomic axis misalignment. * p. patient has active synovitis. * q. patient is a prisoner.
wireless assessment of respiratory and circulatory distress; a pilot study

Conditions: Abdominal Cancer; Postoperative Complications; Respiratory Complication; Circulatory; Complications

Summary: postoperative observation of patients is based on the early warning score (ews). by using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. the object of this pilot study is to test the equipment and methods for the next phases. patients will be monitored for 4 days postoperatively and data is analyzed retrospectively. vital parameters are monitored with ecg, blood pressure monitor and pulseoximetry. in the analysis the investigators will compare the results from the continuous monitoring to the measurements made by the nurses and registered in the ews. the primary outcomes for the pilot study are the frequency of measurements resulting in a single parameter score of 3 according to the ews algorithm.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer of either esophagus, stomach, pancreas, liver, colon or rectum. * elective surgery with curative intention at bispebjerg hospital or rigshospitalet in copenhagen, denmark. * estimated duration of surgery \> 2 hours * \> 65 years * preoperative ecg showing sinus rhythm * no treatment limitations * fit to receive optimized care according to the regimens on the given wards

Keywords: wireless monitoring postoperative complications vital parameters continuous monitoring
leflunomide in systemic lupus erythematosus

Conditions: Systemic Lupus Eythematosus (SLE)

Summary: a pilot study to evaluate the efficacy and safety of leflunomide in sle patients with active disease who are refractory to cyclophosphamide


Eligibility criteria:
inclusion criteria: * fulfill the revised acr criteria for sle with either evidence of active disease according to sle disease activity index (sledai) exclusion criteria: * patients who are pregnant or nursing women, or those with life threatening disease * the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of jnj-64264681 in participants with non-hodgkin lymphoma and chronic lymphocytic leukemia

Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Summary: the purpose of the study is to determine the recommended phase 2 dose(s) (rp2d\[s\]) in b cell non-hodgkin lymphoma (nhl) and chronic lymphocytic leukemia (cll) in part 1 and to evaluate the safety of jnj-64264681 at the rp2d(s) in part 2.


Eligibility criteria:
inclusion criteria: * participants must have eastern cooperative oncology group (ecog) performance status grade of 0 or 1 * participants must have cardiac parameters within the following range: corrected qt interval (qtcf) less than or equal to \<= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes) * women of childbearing potential must have a negative highly sensitive serum pregnancy test (example: beta human chorionic gonadotropin \[beta-hcg\]) at screening, and a negative serum or urine pregnancy test prior to the first dose of study drug * women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration * participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol exclusion criteria: * participant has known active central nervous system (cns) involvement * participant has received prior solid organ transplantation * participant has known allergies, hypersensitivity, or intolerance to jnj-64264681 or its excipients * participant has been treated with an investigational drug (including investigational vaccines) within five half-lives or 2 weeks before the planned first dose of study drug * participant is experiencing toxicities from previous anticancer therapies that have not resolved to baseline levels, or to grade 1 or less (except for alopecia and peripheral neuropathy)
acceptability of a microbiome-directed food in young children with acute malnutrition

Conditions: Malnutrition, Child

Summary: this study will compare the acceptability a microbiome-directed food (mdf) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.

a randomized controlled trial will be conducted to assess the effectiveness of a microbiome-directed food (mdf) for treatment of uncomplicated acute malnutrition among children 6 to \<24 months of age in niger. mdf will be compared to standard ready-to-use therapeutic foods (rutf) for children with severe acute malnutrition (sam) and to standard ready-to-use supplementary foods (rusf) for children with moderate acute malnutrition (mam). the acceptability and utilization of mdf will be assessed in this preliminary acceptability study before the proposed effectiveness trial. the results of this preliminary acceptability study will be used to inform expectations of mdf use during the subsequent randomized effectiveness trial. children aged 6 to \< 24 months will be eligible for enrollment in the acceptability trial on the day of their admission for treatment of uncomplicated severe or moderate acute malnutrition. participants will be purposively selected to ensure balance by child age (6-11 vs 12 to \< 24 months) and sex. recruitment will occur continuously (e.g. without sampling on consecutive working days) among all eligible children at 2 study health centers until the target sample size is achieved. after providing written informed consent, children will be randomized to 1 of 2 feeding orders (mdf vs rutf/rusf). children will be randomized and provided with one product for the first two weeks then crossover to consume the second product for a second two weeks. at each follow up visit, study nurses will ask caregivers rate their child's liking of the supplement on a 5-point likert scale, as well as record child weight and any morbidity or adverse event since last visit before dispensing the next supply of food. caregivers will also be asked to describe at-home utilization, including the food consumed by the child, current eating patterns in relation to other household foods (e.g. use at mealtimes, as a complete replacement, replacement of specific food items), sharing or selling practices in the home and willingness to use the supplement in the future.

Eligibility criteria:
inclusion criteria: * are eligible for outpatient treatment of severe or moderate acute malnutrition according to the national protocol * are between 6 and \<24 months of age * reside in the study catchment area and will remain there for at least 1 month * have no known allergy or contraindication to study product or standard treatment ingredients